Studieoverzicht - 2005-02 MATADOR

Number 2005-02 MATADOR
Nickname MATADOR
Status Follow up Date: 11-10-2012
Inclusion closed
Other study number(s) CKTO 2004-04
Participating parties/groups
Full title Microarray analysis in breast cancer to tailor adjuvant drugs or regimens, a randomized phase III study
Phase and type Randomized Phase II/III
Age ≥ 18; <65
Menopausal status Both pre- and postmenopausal
Indication Adjuvant
Subindication Any HER2, any HR
Target sample size 660
Actual accrual 661 Date: 11-10-2012
Estimated study completion date 01-01-2012
CCMO approval Not applicable Date: Nr:
EudraCT nr.
Trial Register ISRCTN61893718
METC approval Yes Date: 25-03-2004 METC: Nederlands Kanker Instituut Nr: M04MAT
Amendments Yes Date: 27-04-2008
KWF-CKS approval Yes Date: 01-01-2004 Nr: CKTO 2004-04
News item
Sponsor NKI-AVL
Principal Investigator(s) S.C. Linn, H.M. Oosterkamp
Study manager
Central datamanagement and randomization NKI-AVL trialbureau
Plesmanlaan 121
1066 CX Amsterdam
Tel 020 5122668
Fax 020 5122679
Monitoring Not applicable
Local datamanagement IKNL
Funding Logo KWF NweHuisstijl 004-zonder slogan.jpgFunding by KWF


Arm A: Acdd 6 cycles versus
Arm B: TAC: 6 cycles


To define gene expression profiles that can predict a disease-free survival (DFS) advantage for either dose dense therapy, or docetaxel-containing chemotherapy.
Is docetaxel-doxorubicin-cyclophosphamide (TAC) better than doxorubicin-cyclophosphamide dose-dense (AC dd) concerning DFS, RFS, breast cancer specific survival and all cause survival?


Primary endpoints:

  • 5-year disease-free survival
  • To define two subpopulations on the basis of the microarray data: one in which Acdd is best and one in which TAC is best

Secondary enpoints:

  • DFS
  • OS
  • Proteomic profile
Main eligibility criteria:
  • pT1-T3, pN0-3b, M0 mammaca (TNM 2002)
  • Known Her2
  • Women < 65 yrs
  • Tumor tissue available (frozen/RNAlater)
Documents (public):
Documents (protected):
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